Kornimate/medical-research-clean huggingface dataset:
effect of a proprietary dietary supplement on fecal volatile organic compounds

Conditions: Healthy

Summary: the purpose of the study is to determine the effects of both an anthocyanin-rich polyphenol blend and an anthocyanin-rich polyphenol blend combined with a prebiotic blend on fecal microbiota metabolism (assessed by gas chromatograph - mass spectrometry (gc-ms) headspace analysis) and fecal microbiota composition (assessed by next generation sequencing).


Eligibility criteria:
inclusion criteria: * male or female of any race or ethnicity between 18 to 70 years of age, inclusive; * body mass index (bmi) between 20 - 32 inclusive; * non-smoking status; * willing to consume assigned dietary supplements for a total of 6 weeks; * have access to email and a digital camera or camera phone. exclusion criteria: * age \ 70 years; * bmi \ 32; * uncontrolled hypertension defined as diastolic blood pressure ≥95 mm hg or systolic blood pressure ≥160 mm hg; * self-reported presence of atherosclerotic disease and/or cardiopulmonary disease; * renal, hepatic, endocrine, gastrointestinal or other systemic disease; * for women, pregnancy, breast feeding or postpartum less than 6 months; * current participation in another research study; * allergy to the components in the dietary supplement (inulin, fructooligosaccharide, blueberries, black currant, rice); * history of drug or alcohol abuse; * use of antibiotics within the last 6 months; * use of prebiotics or flavonoid-containing dietary supplements within the last 30 days; * multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence; * chronic use of over-the-counter medication which would interfere with study endpoints including nsaids, laxatives and antacids; * participating in or planning to begin a weight loss diet during the study period; * lifestyle or schedule incompatible with the study protocol; * other medical, psychiatric, or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol; * use of tobacco products.
multiple dose escalation study in medically stable subjects with psoriasis

Conditions: Psoriasis; Immunomodulation

Summary: this study was conducted in subjects with psoriasis to evaluate drug activity in this patient population by analysis of changes in psoriatic lesion biopsy characteristics. this subject population was selected to evaluate potentially relevant biological activity of cp-690,550 as well as assessing safety and pharmacokinetics.


Eligibility criteria:
inclusion criteria: * male and/or female subjects between the ages of 18 and 65 years, inclusive, with active psoriasis lesion(s). * subjects should be healthy with the exception of psoriasis, where healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination. blood pressure must be \ 50 kg (110 lbs) * the following laboratory variables must be no more than 10% below the lower limit of the normal reference range: rbc, hemoglobin, hematocrit, wbc, absolute neutrophil count. the absolute lymphocyte count must be greater than or equal to the lower limit of the reference range. values for ast, alt, bilirubin and alkaline phosphatase must be no more than 10% above the upper limit of the normal reference range. values for total cholesterol and ldl must be no more than 20% above the upper limit of the normal reference range except for subjects being treated for hyperlipidemia. normal glomerular filtration rate (\> 80 ml/min). exclusion criteria: * subjects with evidence or history of clinically significant hematological, renal, urological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disorder. * subjects with controlled essential hypertension and/or hyperlipidemia may be eligible for the study provided that any medications that are administered. * screening 12-lead ecg demonstrating at least one of the following: heart rate \> 100 bpm, qrs \>120 msec, qtc \> 430 msec (males), qtc \> 450 msec (females) or pr \> 220 msec. * abnormal chest radiographs including, but not limited to, evidence of past or present tuberculosis infection. history of tuberculosis without treatment and/or positive tuberculin reaction without known vaccination with bcg. * subjects with a history of tumors with the exception of adequately treated basal cell carcinoma of the skin.

Keywords: psoriasis pasi plaques skin biopsy immunomodulation
a follow-up study of rotigotine patch in adolescent subjects with restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: the purpose of this study is to assess the long-term safety, tolerability and the long-term efficacy of rotigotine treatment in adolescents with idiopathic restless legs syndrome (rls).


Eligibility criteria:
inclusion criteria: * subject weighs \>=40 kg * subject has completed at least one dose step in sp1006, a previous study of rotigotine in adolescents with restless legs syndrome (rls), without meeting withdrawal criteria * female subjects must be surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). abstinence is an acceptable method. subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of study drug * subject is expected to benefit from participation, in the opinion of the investigator exclusion criteria: * subject is experiencing an ongoing serious adverse event (sae) that is assessed to be related to rotigotine by the investigator or sponsor * subject has active suicidal ideation as indicated by a positive response ("yes") to either question 4 or question 5 of the "since last visit" version of the electronic columbia suicide severity rating scale (ec-ssrs) at the final evaluation visit of the previous rotigotine study (ie, visit 10 of sp1006)

Keywords: rls neupro rotigotine
breath metabolomics in the laboring parturient

Conditions: Labor Onset and Length Abnormalities

Summary: this is primarily a feasibility study to determine whether quantitative measurement of volatile organic compounds (vocs) in the breath of parturients undergoing labor is possible. aim a: to determine baseline values of breath metabolites and volatile organic compounds (vocs) in the breath for term pregnant women. aim b: to gather preliminary data to determine breath metabolite and volatile organic compound (vocs) signature change during labor and delivery. aim c: compare the breath metabolite and volatile organic compound (vocs) signature women undergoing induction compared to spontaneous vaginal deliveries.

breath metabolites, also known as volatile organic compounds (voc's) are produced during periods of increased stress and as a marker of underlying medical conditions. the goal of this project is to collect vocs within the breath in the initial stages of delivery in otherwise healthy parturients undergoing induction of labor. in addition to a panel of metabolites, we will obtain information on the 3400 compounds which compose the breath metabolome by gas mass spectrometry technology. this is the first step of a larger planned project to develop specialized panels of breath signatures during labor and delivery in parturients. we will collect breath samples at bedside and measure metabolites in the laboratory. this is a feasibility study which we will use to determine normal values for a term parturient and changes of vocs during the course of labor. we will also use this data to construct a power analysis and perform a follow-up study to test whether vocs are associated with different aspects of pregnancy.

Eligibility criteria:
inclusion criteria: * otherwise healthy nulliparous women with singleton term (37-41 weeks) pregnant at least 18 years of age. * presenting for labor (induction of labor and spontaneous labor) at lphc. exclusion criteria: * participants unable to or refuse to give informed consent * participants that do not understand english or are hearing impaired * medical history: chronic disease (htn, diabetes, asthma) * obstetric history during this pregnancy: gestational diabetes, gestational hypertension, pre-eclampsia, eclampsia * multiple gestation * any significant fetal anomalies * morbid obesity (bmi\>50)
prospective analysis of septic associated encephalopathy using the non-invasive acoustocerebrography-acg

Conditions: Encephalopathy; Organ Dysfunction Syndrome

Summary: the patients of the group "sepsis" are measured several times with the non-invasive multi-spectral sonography (sonovum "acg-diagnosesystem") (days 1, 3, 7 and 14). the patients of the group "control" are measured on days 1 and 3 with the system. a measurement takes 3 minutes. for this purpose two ultrasound heads are placed above the patient's ears and fixed with an all-head harness. the device is certified for ce application. there are no known health risks of ultrasound in humans.

sepsis with multiorgan failure is one of the most common diseases in intensive care units and is at the top of the world of causes of death. in addition to increasingly serious sepsis by multidrug-resistant pathogens, neurological symptoms are frequently recorded in the systemic manifestation of the disease pattern. septic encephalopathy (se) is usually an early cerebral sign of the developing sepsis, often before other clinically as well as diagnostically detectable findings such as fever ascent, hypotonia or laboratory chemical infections. therefore, the se is a clinically important parameter, also because after the sepsis, cerebral functional restrictions such as cognitive disorders can persist in the long term. therefore, on day 1, 3, 7 and 14 the patients are measured with the acg-system as well as determined different scores of the patients: cam-icu (confusion assessment method - intensive care unit) and icdsc (intensive care delirium screening checklist) for the neurological outcome; apache (acute physiology and chronic health evaluation) ii for mortality and sofa (sepsis-related organ failure assessment score) for organ failure.

Eligibility criteria:
inclusion criteria: * severe sepsis or septic shock * clinical suspicion of septic encephalopathy * consent to the study by the patient or legal representative * stay in intensive care unit for at least 24 hours without the presence of a septic disease and without clinical guidance for an se exclusion criteria: * inability to consent to participation in the research project or rejection by patients or legal representatives * existence of other causes of delir other than sepsis (e.g., withdrawal) * infrequent prognosis (expected death in ≤ 12 hours despite maximum therapy)

Keywords: severe sepsis encephalopathy
controlled trial to evaluate a local information campaign on antibiotic prescribing in italy

Conditions: Upper Respiratory Tract Infections

Summary: use of information campaigns and educational interventions directed to citizens and supported by physicians, aimed at promoting the appropriate use of medicines, have been evaluated by several studies with conflicting results. these interventions are potentially relevant, favouring the reduction of unnecessary use of medicines and related risks. several studies have specifically evaluated the promotion of the appropriate use of antibiotics in adults and children, with variable results. a controlled study has been proposed to evaluate the feasibility and effectiveness of a multifaceted intervention aimed at reducing antibiotic prescription by increasing awareness on risks of their unnecessary use. information has been provided to citizens through several media (posters, local tv, radio and newspapers, video terminals, websites of local health authorities). brochures with information on expected benefits and risks of antibiotics has also been available, either with direct access in waiting rooms and pharmacies or handed out and mediated by doctors. physicians and pharmacists received specific data on local antibiotic resistance. a small group of representative doctors have also actively participated in defining the campaign key messages. a sample of general practitioners and paediatricians have been trained in patient counselling strategies. the information campaign has been implemented in two provinces of emilia-romagna during the fall-winter season (november 2011-february 2012). change in the overall prescribing rate of antibiotics (expressed as ddd per 1000 inhabitants/day) in the intervention area will be compared versus other areas in the same region. knowledge and attitudes of the general population will be evaluated through a phone and internet survey on a representative sample. this study could observe a reduction lower than 5% in the prescribing rate of antibiotics.


Eligibility criteria:
inclusion criteria: * the campaign has been targeted at the general population in the intervention areas

Keywords: information campaign antibiotics bacterial resistance primary care
influence of high intensity exercise on insulin resistance, muscle contractile properties, aerobic capacity and body composition in multiple sclerosis

Conditions: Multiple Sclerosis; Healthy Controls

Summary: the purpose of this study is to investigate the effects of a combined training programme and a high intensity interval training programme on insulin resistance, muscle strength/ muscle contractile properties, aerobic capacity and body composition in ms patients. it is assumed that the the above mentioned clinical parameters will improve due to physical exercise.


Eligibility criteria:
inclusion criteria: * diagnosed ms according to the mcdonald criteria * expanded disability status scale (edss) between 0.5 and 6 * be able to train 5 times in 2 weeks at the university exclusion criteria: * comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases (like diabetes type 2) * having had an relapse in a period of 3 months prior to the start of the intervention period * having an relapse during the intervention period * pregnancy and other contra indications for physical activity * mental disorders

Keywords: high intensity interval training combined training insulin resistance muscle contractile properties
multicenter cohort of stemi patients

Conditions: STEMI - ST Elevation Myocardial Infarction

Summary: ischemic heart disease is the leading cause of mortality with 7.2 million of death in industrialized countries (who data). myocardial infarction corresponding to acute occlusion of a coronary artery is the most brutal form and the more severe ischemic myocardial disease. every year in france, about 60,000 myocardial infarctions hospitalized, 30,000 are diagnosed remotely and 30,000 are revealed by an inaugural sudden death. although mortality from myocardial decreased by 30% over the past decade, the prognosis is pejorative and difficult to assess precisely. the management of the patient depends on these factors, and justifies an active search on these topics, including the mechanisms of the deleterious ventricular remodeling, myocardial inflammation, reperfusion injury which determines in particular the evolution to heart failure. cohorts of patients with myocardial infarction are rare but can be very valuable by their clinical, laboratory and imaging well documented. they are the source of new hypotheses for research or interventions as well as the quality of care assessment tool. the main objective of this project is to identify new markers: biological and imaging, treatment response and prognosis after acute myocardial infarction. secondary objectives of the hibiscus-stemi cohort to establish a clinical database, completed by biological samples and by imaging data that can be used in the following areas: * descriptive epidemiology of myocardial infarction and myocardial reperfusion * pharmacoepidemiology and treatments observatory: safety, efficacy, indication of treatment in real life, costs * assessment of the long-term effect of the treatment on the occurrence of heart failure and sudden death * quality of life and personal consequences, family, professional and social myocardial infarction * research of new diagnostic and prognostic biomarkers * research projects (e.g. risk of developing kidney failure or stroke in patients with myocardial infarction compared to the general population).


Eligibility criteria:
inclusion criteria: * age \> 18 years old * diagnosis of stemi defined by st segment elevation ≥ 0.2 mv in 2 contiguous leads on a 12-lead ecg. * primary percutaneous coronary intervention (pci) exclusion criteria: * diagnosis of stemi not confirmed by angiography * refusal to participate in the study or to sign the consent * impossibility to give information to the subject about the study * lack of medical social coverage * obvious contraindication to magnetic resonance imaging (claustrophobia, pacemaker, defibrillator, renal insufficiency, known allergy to a contrast agent) * deprivation of civil rights * participating to another interventional study

Keywords: myocardial infarction bio-collection imaging markers biomarkers stemi clinical outcomes
impact of pregabalin in chronic users vs. a perioperative limited prescription on oxycodone requirement

Conditions: Postoperative Pain; Neuropathic Pain

Summary: spinal surgery is associated with intense pain and associated to a history of preoperative chronic pain. pregabalin is licensed to treat chronic neuropathic pain, particularly when high dose of opioid are required. preoperative pain is associated with high postoperative pain scores and opioid requirement promoting persistent hyperalgesic state. the investigators will evaluate the postoperative opioid consumption and pain scores in patients scheduled for lumbar surgery and taking pregabalin since more than 15 days and compare with preoperative pregabalin-free patient that will receive pregabalin only during surgery.

patients will be prospectively included and compared according their preoperative medication: pregabalin-treated patients (\>more than 15 days) for neuropathic pain associated to spinal surgery and pregabalin-free patients for whom pregabalin will be prescribed for 48 hours. patients will be included without randomization as an observational study. all the patients will receive multimodal analgesia and intraoperative management will be standardized. the main outcome will be the amount of oxycodone during the first 24h after surgery. other outcomes include pain scores, the quantification of the neuropathic pain diagnostic questionnaire (dn4), nausea and vomiting, length of stay, side-effects of pregabalin and opioid. patients were also evaluated at three months for pain scores and dn4 score. postoperative evaluation will be performed in a single-blind manner with investigators not include in the recruitment or the peroperative period.

Eligibility criteria:
inclusion criteria: * american society anesthesiologist physical status (asa) 1-3 * age ≥18 years old * spinal surgery: discectomy, posterior or transforaminal lumbar interbody fusion limited to 2 levels, lumbar disk prosthesis * able to participate personality, has given free and inform consent in french * affiliated of beneficiary of a system of social security exclusion criteria: * age less than 18 years or higher than 85 years old * refusal to participate or provide written consent * surgery with a combined anterior and posterior approach * emergency surgery, reintervention, spine fracture, metastasis * tricyclic antidepressant use * pregabalin use for other indication: other neuropathy, epilepsy, generalized anxiety disorder * pregnancy * lack of understanding of nrs and/or dn4 scores * hypersensibility or contraindication to levobupivacaine, paracetamol, nefopam, ketoprofen and/or oxycodone * participation in another clinical study

Keywords: chronic pain oxycodone pregabalin lumbar spine surgery multimodal analgesia
xpert hepatitis-c virus (hcv) test on the genexpert xpress system

Conditions: HCV

Summary: a multi-site prospective, all comers study that was conducted at geographically diverse locations in the united states.

whole blood specimens were collected from consented individuals with signs and symptoms and/or individuals at-risk of hcv infection, irrespective of hcv antibody status at a single timepoint.

Eligibility criteria:
inclusion criteria: * participant was ≥18 years old * participant was not on treatment at time of enrollment based on review of medical records or self-reported * participant had signs and symptoms and/or is considered at-risk of hcv infection exclusion criteria: * clinician assessed that the participant was not suitable for inclusion
abdominal sepsis study: epidemiology of etiology and outcome

Conditions: Intra-Abdominal Infections

Summary: the aim of the project is to perform a multinational, prospective, observational study on iais (intraabdominal infections) in critically ill patients; special emphasis will be given to epidemiology and outcomes.

to investigate microbiology and/or drug resistance patterns related to: geographical region, source of iai, upper gi tract perforation (stomach \& duodenum), lower gi tract perforation (jejunum, ileum, colon, rectum), primary peritonitis, peritoneal dialysis-related peritonitis, intra-abdominal abscess, pancreatic infection, biliary tract infection, typhlitis, toxic megacolon. to check the origin of iai: community-acquired, early-onset healthcare-associated, late-onset healthcare-associated. to describe physician's antimicrobial prescription patterns related to a classification grid that stratifies iais according to disease expression, community or healthcare origin, and anatomical disruption. to investigate outcomes (clinical response, need for surgical revision, length of hospitalization, and mortality) related to: classification of iai, severity of acute illness at time of diagnosis (sofa score) and clinical response after 48-72 hrs. (sofa score), processes of care (time to 1st antimicrobial dose, time to source control, type of source control intervention (laparotomy, percutaneous drainage, high volume peritoneal lavage, restoration of anatomy and function), need for (unplanned) surgical revision (uncontrolled infection source), frequency of microbiological sampling and delay of results)), pathogens involved and empirical antimicrobial coverage; special emphasis will be given, to coverage of multidrug resistant enterobacteriaceae, pseudomonas aeruginosa, enterococci and candida species, duration of antimicrobial therapy, underlying conditions

Eligibility criteria:
inclusion criteria: * adult (≥18 yrs. of age) * iai treated with percutaneous or surgical procedure * icu admission (the patient should either be admitted to the icu because of abdominal sepsis or should be admitted in the icu for other reasons and subsequently developed abdominal sepsis as a complication during the icu course) * informed consent (if required by local ethics committee) exclusion criteria: \<18 yrs

Keywords: abdominal sepsis sepsis septic shock epidemiology etiology microbiology abdomen intra-abdominal infection gastrointestinal tract perforation peritonitis pancreas biliary tract megacolon
assessment of the role of incisura biopsy in the staging of chronic gastritis

Conditions: Chronic; Gastritis, Atrophic

Summary: this prospective multicenter study investigates the added benefit of incisura biopsy to correct identification of patients with high-risk chronic gastritis (olga stages iii-iv). it compares a biopsy protocol with and without a single incisura biopsy in a non-inferiority design.


Eligibility criteria:
inclusion criteria: * indication to perform upper gi endoscopy for diagnosis or surveillance exclusion criteria: * lack of informed consent, previously diagnosed advanced gastric cancer, incomplete endoscopy, surgically altered stomach